Discussions and Activity at the Federal Level Regarding Management of Electronic Medical Equipment

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1 Discussions and Activity at the Federal Level Regarding Management of Electronic Medical Equipment Lynne Sehulster, PhD, M(ASCP) Health Scientist Best Practices in Medical Device Cleaning and Disinfection November 4, 2010 National Center for Emerging and Zoonotic Infectious Diseases Division of Healthcare Quality Promotion Disclaimer / Disclosure The findings and conclusions in this presentation are those of the author and her information resources and do not necessarily represent any determination or policy of the Centers for Disease Control and Prevention (CDC). The author is an employee of the Federal government (DHHS) and has no commercial affiliations or conflicts of interest to disclose. 1

2 FDA Takes Note of Medical Equipment-Associated Adverse Events Equipment / device adverse events from were reviewed Common observation: inappropriate use of liquids on electronic medical equipment Problems reported: Equipment fires and other damage Equipment malfunction Healthcare worker injuries (i.e., burns) Potential for adverse effects on patients o Possible adverse events could include over-infusion of medications, loss of life-supporting drug therapy, and loss of patient ventilation * FDA MedWatch Reporting FDA Takes Note of Medical Equipment-Associated Adverse Events Equipment / device adverse events from were reviewed Wide variety of equipment involved (including but not limited to): Infusion pumps, ventilators, patient-controlled analgesia pumps, sequential compression device pumps, telemetry devices, infusion fluid warmers, infant anti-abduction sensors Potential problem of equipment damage could also become associated with any equipment with unsealed electronic circuitry or components Computer keyboards, hand-held devices, monitoring devices. FDA MedWatch Reporting 2

3 FDA Takes Note of Medical Equipment-Associated Adverse Events FDA conducts interviews with healthcare workers and observes equipment management practices Healthcare workers routinely sprayed the equipment housings with disinfectants or wrapped the housings with disinfectantsoaked towels Equipment instructions were often not available, and/or the instructions did not provide adequate information about the daily maintenance of the equipment When manufacturers instructions were available and reviewed, many would recommend wiping the housing with a soft cloth dampened with a mild detergent and water FDA MedWatch Reporting Link: 3

4 CDC Recommendations E. Recommendations Environmental Services I. Cleaning and Disinfecting Strategies for Environmental Surfaces in Patient-Care Areas A. Select EPA-registered disinfectants, if available, and use them in accordance with the manufacturer s instructions.2, 974, 983 Category IB, IC (EPA: 7 United States Code [USC] 136 et seq) B. Do not use high-level disinfectants/liquid chemical sterilants for disinfection of either noncritical instrument/devices or any environmental surfaces; such use is counter to label instructions for these toxic chemicals.951, 952, Category IB, IC (FDA: 21 CFR 801.5, e) CDC / HICPAC Guidelines for Environmental Infection Control in Health-Care Facilities. Available at: CDC Recommendations (continued) C. Follow manufacturers instructions for cleaning and maintaining noncritical medical equipment. Category II D. In the absence of a manufacturer s cleaning instructions, follow certain procedures. 1. Clean noncritical medical equipment surfaces with a detergent/disinfectant. This may be followed with an application of an EPA-registered hospital disinfectant with or without a tuberculocidal claim (depending on the nature of the surface and the degree of contamination), in accordance with disinfectant label instructions.952 Category II 2. Do not use alcohol to disinfect large environmental surfaces.951 Category II 3. Use barrier protective coverings as appropriate for noncritical equipment surfaces that are 1) touched frequently with gloved hands during the delivery of patient care; 2) likely to become contaminated with blood or body substances; or 3) difficult to clean (e.g., computer keyboards).936 Category II CDC / HICPAC Guidelines for Environmental Infection Control in Health-Care Facilities. Available at: 4

5 Identify the equipment for which the notification applies Obtain equipment manufacturer s labeling / instructions Instructions attached / affixed to the equipment User guide or manual Information from the manufacturer website Look for cautions, precautions, or warnings about wetting, immersing, or soaking the equipment If these cautionary statements are found, the recommendations of the Public apply Review the equipment manufacturer s cleaning and maintenance instructions First consideration Look for the recommended cleaning process Look for manufacturer-recommended cleaning and if needed, disinfection active ingredients Ensure all staff assigned to managing the medical equipment are trained and will follow the instructions 5

6 Protect equipment from contamination whenever possible Engineering controls: Barriers on the equipment or surfaces Careful work practices to avoid contaminating the equipment Avoid unnecessary touching of the equipment during care delivery, especially with contaminated hand or gloves Position the equipment to avoid contact with anticipated spatter Avoid laying contaminated items on unprotected equipment surfaces From Point A to Point B Medical/Dental Instruments and Accessories Patient A Physicians, Nurses, and Assistants Patient B Medical Equipment, Environmental Surfaces, Frequently Touched Surfaces 6

7 The Inanimate Environment Can Facilitate Transmission X represents VRE culture positive sites ~ Contaminated surfaces increase cross-transmission ~ Abstract: The Risk of Hand and Glove Contamination after Contact with a VRE (+) Patient Environment. Hayden M, ICAAC, 2001, Chicago, IL. Minimize Glove Misuse Failure to remove or change contaminated gloves 18.3% (4/22) samples showed potential transferral of microorganisms [a = from patient, b = from gloves] Source: Girou E, Chai SHT, Oppein F, et al. J Hosp Infect 2004; 57: Glove Cultures Environmental Cultures # of Contacts Prior to Sampling Bacterial Counts (CFU) Pathogenic Bacteria Sampled Surfaces Bacterial Counts (CFU) Pathogenic Bacteria 6 4,500 P. aeruginosa (a), Serratia marcescens (a) Bed barrier (rail) 85 P. aeruginosa, Serratia marcescens (a, b) 10 >30,000 P. aeruginosa 10 >30,000 P. aeruginosa 17 >30,000 P. aeruginosa Bedside table Bedside table Weighing machine 2 P. aeruginosa >300 P. Aeruginosa (a) 169 P. aeruginosa (b) 7

8 If there is suspicion of equipment contamination with microorganisms that might pose a transmission risk in healthcare settings (e.g., Contact precautions), do the following: Clean the equipment surfaces in accordance with instructions from both the equipment manufacturer and the cleaning / disinfection chemical manufacturer(s) If disinfection is necessary, alternative strategies to avoid wetting should be explored with the equipment manufacturer Note: Use these opportunities to encourage equipment manufacturers to provide alternative instructions, redesign their equipment to protect the electronics Always adhere strictly to all the chemical manufacturer s warnings, precautions and cautions Carefully follow all directions for chemical usage: Is a precleaning step indicated? Concentration or dilution vs. ready to use Method of application Contact time (time necessary to achieve disinfection) Reapplication of the product may be necessary Question for EPA: Define wet, or wetness Detergent / disinfectants (i.e., combination products, one-step products ) Usually two sets of instructions, one for use of the product as a cleaner, the other for using the product to disinfect 8

9 If the equipment is contaminated with blood or other potentially infectious material (OPIM), the equipment must be decontaminated per OSHA regulations Follow the equipment manufacturer s directions for cleaning to remove as much soil as possible It may be necessary to remove the equipment from service for thorough cleaning and disinfection. Points for Discussion and Debate Consider this statement from the Additional Information section of the Public : Be advised that not all equipment handling or patient contact results in the need for disinfection. None of the documents from the relevant Federal agencies is intended to require disinfection of equipment that has not become contaminated. Issues concerning acceptance of barrier coverings What about surface contamination via aerosols? What about a clean hands assistant? 9

10 Thank You! For more information please contact Centers for Disease Control and Prevention 1600 Clifton Road NE, Atlanta, GA Telephone, CDC-INFO ( )/TTY: Web: The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention. National Center for Emerging and Zoonotic Infectious Diseases Division of Healthcare Quality Promotion 10